MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH EM-TEC ADULT FLOW PROBE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	201-30105
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Hemodynamic instability (4868)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4 - patient weight was not provided by customer.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Event or Problem Description
It was reported that the flow had to be set "quite high" in order to get it to flow at all, then come back down a bit.A few hours later in cardiovascular, flows were lost again and had to switch to another circuit.There was some clotting in the venous cannula.The customer reported concern regarding the flow probe, although unlikely as it was noted there was also a correlation between hemodynamics and the event.The centrimag console was exchanged.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of atypical flow values occurring on the centrimag system was confirmed via the log file.The log file captured several intermittent f2: flow signal interrupted and f3: flow below minimum alarms on 13oct2025 while the system was in use.These alarms appeared to have been caused by the flow values fluctuating below the alarm thresholds.The alarms did not prevent the system from operating at the set speed throughout the data, and the system was observed to have been manually shut down at the end of the data to perform the reported equipment exchange.The returned centrimag flow probe (serial number (b)(6) was functionally tested at the service depot alongside the returned motor and console (each evaluated separately).The returned equipment was found to function as intended, and atypical events were unable to be reproduced throughout all testing.The serviced and tested flow probe was returned to the customer site after passing all tests per procedure.Questions regarding the event were asked multiple times and no responses were received.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for the centrimag flow probe, serial number 131494, showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 4 "warnings and precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual section 12.1-"appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including flow-related alarms, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: EM-TEC ADULT FLOW PROBE
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23547839
• Report Number: 3003306248-2025-00320
• Device Sequence Number: 13191492
• Product Code: QNR
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K020271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 201-30105
• Device Catalogue Number: 201-30105
• Device Lot Number: 7458302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown